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Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary embolism, Dyspnea, Post Pulmonary Embolism Syndrome, PPS, Rehabilitation, Cardiac magnetic resonance imaging (CMR)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Objectively diagnosed symptomatic pulmonary embolism by CTPA or high-probability scintigraphy 6 months to 6 years before inclusion
  • Persistent dyspnea defined as modified Medical Research Council (mMRC) breathlessness scale >= 1 that has appeared or worsened after the diagnosis of PE (eligibility criteria for randomization)

Exclusion Criteria:

  • Significant pulmonary disease (COPD GOLD >= 2, restrictive pulmonary disease, lung cancer or pleural disease.
  • Heart failure (either HFrEF, HFmrEF or HFpEF as defined in ESC guidelines)
  • Significant valvular heart disease
  • Chronic thromboemboli pulmonary hypertension (CTEPH)
  • Patients unfit for rehabilitation or walking tests du to old age, physical disability or disease
  • Patients with a history of poor compliance or any condition that would interfere with the ability to comply with the study protocol e.g. history of drug abuse, excessive alcohol beverage consumption, cognitive dysfunction or severe psychiatric disease
  • Active malignancy
  • Life expectancy less than 3 months
  • Pregnancy

Sites / Locations

  • The hospital of Østfold, Kalnes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rehabilitation

No rehabilitation

Arm Description

Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.

Patients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.

Outcomes

Primary Outcome Measures

ISWT
Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study

Secondary Outcome Measures

mMRC
The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale
Sensewear
The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)
HRQoL by EQ-5d
The effect of rehabilitation on HRQoL measured by EQ-5D
HRQoL by PEmb-QoL
The effect of rehabilitation on HRQoL measured by PEmb-QoL
Long term effect of physical capacity
The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation
Test-retest reliability of the ISWT in this patient population
Test-retest reliability of the ISWT in this patient population
Minimum clinically important difference for ISWT
Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.
Proportion of patients who achieves the established minimum clinically important difference
Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population

Full Information

First Posted
January 11, 2018
Last Updated
September 26, 2022
Sponsor
Ostfold Hospital Trust
Collaborators
University Hospital, Akershus, Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03405480
Brief Title
Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism
Official Title
Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism - a Randomized Controlled Trial - The REHAB Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
University Hospital, Akershus, Ullevaal University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS).
Detailed Description
The newly identified Post Pulmonary Embolism Syndrome (PPS) is characterized by chronic persistent, but unexplained dyspnea (i.e. without signs of pulmonary hypertension or pulmonary abnormality). Symptoms are considerable, but less severe than in CTEPH patients. A recent study performed by our group confirmed that up to 50% of our patients complained of various grades of persistent unexplained dyspnea 1-10 years after the diagnosis of PE. In this multifaceted project we wish to evaluate the effect of an eight week rehabilitation program led and supervised by a trained physiotherapist on exercise capacity in PPS patients. This interventional part of the study will be formed as a randomized controlled trial. Patients will be randomized to either usual care or a physiotherapist-supervised rehabilitation program. The study also aims to explore potential underlying pathophysiological mechanisms in PPS, using state of the art methods such as cardiac magnetic resonance imaging and transthoracic echocardiography involving novel methods focusing on the right ventricle. The pathophysiological part of the study will be formed as a case control study, where post PE-patients who do not fulfill the criteria for PPS will serve as controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary embolism, Dyspnea, Post Pulmonary Embolism Syndrome, PPS, Rehabilitation, Cardiac magnetic resonance imaging (CMR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation
Arm Type
Experimental
Arm Description
Physiotherapist-supervised outpatient rehabilitation program 2 times a week for a total of 8 weeks.
Arm Title
No rehabilitation
Arm Type
No Intervention
Arm Description
Patients will receive usual care, including information pamphlets with information on the disease and the general importance of exercise.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Rehabilitation
Primary Outcome Measure Information:
Title
ISWT
Description
Change in "Incremental Shuttle Walk Test" will be primary endpoint for interventional part of the study
Time Frame
ISWT wil be performed at 12 weeks and 36 weeks after baseline
Secondary Outcome Measure Information:
Title
mMRC
Description
The effect of rehabilitation on dyspnea measured by mMRC breathlessness scale
Time Frame
12 weeks and 36 weeks after inclusion
Title
Sensewear
Description
The effect of PRP on daily physical activity as measured with an activity monitor (Sensewear)
Time Frame
12 weeks and 36 weeks after baseline
Title
HRQoL by EQ-5d
Description
The effect of rehabilitation on HRQoL measured by EQ-5D
Time Frame
12 weeks and 36 weeks after baseline
Title
HRQoL by PEmb-QoL
Description
The effect of rehabilitation on HRQoL measured by PEmb-QoL
Time Frame
12 weeks and 36 weeks after baseline
Title
Long term effect of physical capacity
Description
The long-term effect of rehabilitation on physical capacity measured by ISWT, 6 months after completing the rehabilitation
Time Frame
6 months after completing rehabilitation
Title
Test-retest reliability of the ISWT in this patient population
Description
Test-retest reliability of the ISWT in this patient population
Time Frame
At baseline, 12 weeks and 36 weeks
Title
Minimum clinically important difference for ISWT
Description
Establish the minimum clinically important difference (MID) for the ISWT in patients with PPS expressed in meters.
Time Frame
36 weeks after baseline
Title
Proportion of patients who achieves the established minimum clinically important difference
Description
Proportion of patients who achieves the established minimum clinically important difference for ISWT for this population
Time Frame
36 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Myocardial fibrosis evaluated by cardiac MRI
Description
The primary objective in the pathophysiology part of the study is to investigate whether diffuse myocardial fibrosis shown by CMR is associated with PPS
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Objectively diagnosed symptomatic pulmonary embolism by CTPA or high-probability scintigraphy 6 months to 6 years before inclusion Persistent dyspnea defined as modified Medical Research Council (mMRC) breathlessness scale >= 1 that has appeared or worsened after the diagnosis of PE (eligibility criteria for randomization) Exclusion Criteria: Significant pulmonary disease (COPD GOLD >= 2, restrictive pulmonary disease, lung cancer or pleural disease. Heart failure (either HFrEF, HFmrEF or HFpEF as defined in ESC guidelines) Significant valvular heart disease Chronic thromboemboli pulmonary hypertension (CTEPH) Patients unfit for rehabilitation or walking tests du to old age, physical disability or disease Patients with a history of poor compliance or any condition that would interfere with the ability to comply with the study protocol e.g. history of drug abuse, excessive alcohol beverage consumption, cognitive dysfunction or severe psychiatric disease Active malignancy Life expectancy less than 3 months Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed Ghanima, MD. Assoc.Prof
Organizational Affiliation
Hospital of Østfold, Kalnes
Official's Role
Study Director
Facility Information:
Facility Name
The hospital of Østfold, Kalnes
City
Grålum
ZIP/Postal Code
1714
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34127618
Citation
Fabyan KD, Holley AB. Postpulmonary embolism syndrome. Curr Opin Pulm Med. 2021 Sep 1;27(5):335-341. doi: 10.1097/MCP.0000000000000789.
Results Reference
derived
PubMed Identifier
33407792
Citation
Haukeland-Parker S, Jervan O, Johannessen HH, Gleditsch J, Stavem K, Steine K, Spruit MA, Holst R, Tavoly M, Klok FA, Ghanima W. Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. Trials. 2021 Jan 6;22(1):22. doi: 10.1186/s13063-020-04940-9.
Results Reference
derived

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Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

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